IMAGE

QUALITY CONTROL MANUAL

Quality Control Procedures
for the Technologist and Medical Phisicist

MANUAL CODE M 173

REVISION 0.0

S.r.l. - Bologna - Italy

Via SAGITTARIO, 5 40037 - Pontecchio Marconi - Bologna - ITALY - Tel. (051) 846851 - Fax (051) 846856
E - MAIL: Export Dept.: imscomm@imsitaly.com - Tecnical Dept.: imstech@imsitaly.com
Many thanks for having selected our GIOTTO IMAGE mammography unit.
I.M.S. is known across the world for its quality, high-tech radiology units.
The following manuals will help you to familiarise yourself with the GIOTTO IMAGE unit, supplying you
with all the necessary information for correct use and providing advice on maintenance and safekeeping of
the unit.
All rights of this publication are reserved for Messrs I.M.S. Any reproduction or dissemination, whether
complete or partial, that has not been duly authorised in writing, is absolutely forbidden.
This manual cannot be reproduced, transmitted, transcribed, archived in a retrieval system or translated into
other languages without prior written approval by I.M.S.
The buyer may reproduce copies for his/her/its internal use.

I.M.S. S.r.l. reserves the right to change at any time and without prior notice the technical and aesthetic
characteristics of the products mentioned here - the said characteristics are, therefore.

This manual is structured to supply essential information for correct use of the unit: GIOTTO IMAGE.
It is an essential part of the supply, and must therefore be kept together with the machine’s other technical
documentation for the life time of the machine.
The subjects dealt with are exclusively aimed at specialist users.
Before carrying out any operation, ensure that you have read and understood the contents of this manual.
The Manufacturer declines all liability for damage of any kind, caused by incorrect use, negligence, superficial
interpretation or failure to observe the safety conditions indicated in this manual.

CONFORMITY OF THE EQUIPMENT

• This machine is certified as fixed installation medical-electrical equipment and was built in conformity
with the applicable provisions of directive 93/42/EEC concerning medical devices and of Law Decree No.46
of 24.02.97 “Implementation of Directive 93/42/EEC concerning medical devices”, amended by “Law Decree
No.95 of 25.02.98.

CE Certificate No.: 7505 0459

CLASSIFICATION OF THE EQUIPMENT

IEC 60601-1 class I

IEC 60601-1 type B
93/42/CEE (MDD) class II B
FDA class II

I.M.S. S.r.l.
Via SAGITTARIO, 5
40037 - Pontecchio Marconi
Bologna - ITALY
Tel. (051) 846851
Fax (051) 846856
E - MAIL:
Export Dept.: imscomm@imsitaly.com
Tecnical Dept.: imstech@imsitaly.com

2/56
CHECKS AND REGULATIONS

1. BEAM QUALITY ASSESSMENT

(HALF-VALUE LAYER MEASUREMENT)
2. KVp ACCURACY AND REPRODUCIBILITY
3. BREAST ENTRANCE EXPOSURE, AEC REPRODUCIBILITY,
AVERAGE GLANDULA DOSE, AND RADIATION OUTPUT RATE
4. CHECK OF LIGHT FIELD INTENSITY AND UNIFORMITY
5. PROCEDURE COLLIMATION ASSESSMENT
6. EVALUATION OF SYSTEM RESOLUTION
7. AUTOMATIC EXPOSURE CONTROL DELL’AEC SYSTEM
PERFORMANCE ASSESSMENT
8. PROCEDURE SYSTEM ARTIFACT EVALUATION
9. PROCEDURE IMAGE QUALITY EVALUATION
10. PROCEDURE: COMPRESSION
11. COMPRESSION PADDLE ALIGNMENT
12. CHECK-LIGHT FIELD EDGE CONTRAST
13. X-RAY SHIELDING COMPLIANCE
14. LEAKAGE CHECK-X-RAY TUBEHEAD

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CONTROLLI E REGOLAZIONI

1. BEAM QUALITY ASSESSMENT (HALF-VALUE LAYER MEASUREMENT)

When starting the unit set the function of continuous exposure.

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5/56
CORRECTIVE Verify kV value with invasive system (high-tension
ACTION probe and oscilloscope).
Replace filter of X-ray tube window.
Replace X-ray tube.

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* Without compressor

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2. KVp ACCURACY AND REPRODUCIBILITY

Regulate reference tension values so that they can be within the requested
tolerance values.

CORRECTIVE Check that feed tension, 230V AC ± 10%, is within the required limits especially
ACTION during exposures. Check anodic current regulation.
Check kV and mA wave shapes on inverter control sheet test points (by means of
the PARAM IMAGE).

8/56
 KVp ACCURACY AND REPRODUCIBILITY
Equipment used: Calibration expiry date:
Prototype test Output test

kVp setting
Machine focal sizes
Exposure time
mAs setting
kVp measured values
kVp1
kVp2
kVp3
kVp4
kVp average <kVp>
Standard deviation σkVp
Additional kVp sizes (when necessary)
kVp5
kVp6
kVp7
kVp8
kVp9
kVp10
Recalculation
kVp average <kVp>
Standard deviation σkVp
(use 10 readings)
<kVp> nominal kVp
0.05 nominal kVp
kVp coefficient of variation

SAMPLING PLAN: level 2

Acceptability limits:
± 4% o ± 1 kVp on nominal value C. V.: ≥ 0.02

Corrective action: replace generator

DATE SIGNATURE

9/56
3. BREAST ENTRANCE EXPOSURE, AEC REPRODUCIBILITY, AVERAGE
GLANDULA DOSE, AND RADIATION OUTPUT RATE

Attention: Giotto mammography machines carry out impulsive exposures,

some instruments may turn out to be unfit to measure the correct dose
values, in fact they reset automatically once an exposure is finished and
the following begins.

2.

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 1

F. 1

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12/56
Use PARAM program. “Last exposure” data displayed value.

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 X-Ray Tube Voltage (kVp) W/Al
Target-Filter
HVL 23 24 25 26 27 28 29 30 31 32 33 Combination

0.23 116
0.24 121 124
0.25 126 129 131
0.26 130 133 135 138
0.27 135 138 140 142 143
0.28 140 142 144 143 147 149
0.29 144 146 148 150 151 153 154
0.30 149 151 153 155 156 157 158 159 170
0.31 154 156 157 159 160 161 162 163 164 175
0.32 158 160 162 163 164 166 167 168 168 170 171 180
0.33 163 165 166 168 169 170 171 173 173 174 175 185
0.34 168 170 171 172 173 174 175 176 177 178 179 190
0.35 174 175 176 177 178 179 180 181 182 183 194
0.36 179 181 182 183 184 185 185 186 187 199
0.37 185 186 187 188 189 190 191 191 204
0.38 190 191 192 193 194 195 195 208
0.39 196 197 198 198 199 200 213
0.40 201 202 203 204 204 217
0.41 206 207 208 208 221
0.42 211 212 212 225
0.43 215 216 230
0.44 220 234
0.45 238

To convert from entrance exposure in air in roentgens to mean glandular breast dose in millirads,
multiply the entrance exposure by the factor shown in the table for the appropriate kVp and beam
quality (HVL) combination. For example, a measured entrance exposure of 0.50 röntgens from a
Mo/Mo target/filter system at 30 kVp with a measured HVL of 0.36 mm. aluminum yields an
average glandular dose of (0.50R) x (185 mrad/R) = 93 mrad or 0.93 mGy.

* Adapter from: Wu X. Breast dosimetry in screen-film mammography. In Barnes GT, Frey GD

(eds), Screen-film mammography: Imaging Considerations and Medical Physics
Responsabilities. Madison, Wis: Medical Physics Publishing; 1991; 159-175. W/Al sconversion
factors are derived from fits to data from Stanton L., et. Al. Dosage evaluation in mammography.
Radiology 1984; 150: 577-584.

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 X-Ray Tube Voltage (kVp)

HVL 25 26 27 28 29 30 31 32 33 34 35

0.28 149 151 154

0.29 154 156 158 159
0.30 158 160 162 162 162 163
0.31 163 164 166 166 166 167 167
0.32 167 169 171 171 171 171 172 172
0.33 171 173 175 176 176 176 176 177
0.34 176 178 179 179 180 180 180 181 181
0.35 180 181 183 183 184 185 185 186 187
0.36 185 186 187 187 188 188 189 190 191 191
0.37 189 190 191 191 192 193 193 194 195 195
0.38 193 194 196 196 197 197 197 198 199 199 200
0.39 198 199 200 200 201 201 202 202 203 203 204
0.40 202 203 204 204 205 205 206 207 208 208 208
0.41 206 207 208 208 209 209 210 211 212 212 212
0.42 211 211 212 212 213 213 214 215 216 216 217
0.43 215 216 217 217 218 218 219 219 220 220 221
0.44 220 220 221 221 222 222 223 223 224 224 225
0.45 224 224 225 225 226 226 227 227 228 228 229
0.46 228 229 229 230 231 231 232 233 233 234
0.47 233 233 234 235 235 236 237 237 238
0.48 238 238 239 240 240 241 241 242 242
0.49 242 243 243 244 244 245 245 246
0.50 247 247 248 248 249 250 251
0.51 251 252 253 254 254 255
0.52 257 257 258 258 259
0.53 261 261 262 263 264
0.54 265 266 267 268
0.55 269 270 271 272
0.56 275 276 276
0.57 279 280 281
0.58 284 285
0.59 288 289
0.60 293

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 CORRECTIVE Check kV wave shapes using invasive system or by means of the visualization
ACTION of PARAM IMAGE program graphics; dose wave shape should be perfectly
flat. For further information please contact IMS technical service support
center.

X-RAY SENSOR SIGNAL

SI NO

EXPOSURE TIME EXPOSURE TIME

F. 2

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17/56
4. CHECK OF LIGHT FIELD INTENSITY AND UNIFORMITY

F. 3

3/a .

If necessary remove the tubehead cover, loosen the two screw

that secure the lamp socket to the lamp cradle (Figure 3/a).
Increase the light field illuminance by adjusting the lamp
position within the cradle. Move the lamp collimator so that REGULATION SCREWS
the lamp filament is centered with reference to the hole. Tighten
the screw, replace the tubehead cover, then repeat the test.

CENTERING HOLE

CORRECTIVE ACTION
F. 3/a

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5. PROCEDURE COLLIMATION ASSESSMENT

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F. 4 LEGEND

A - 18x24 cassette properly inserted

B - 24x30 reveresed cassette

C - nr. 4 coins (or clips) placed on cassette, on the light field edge.

D - nr. 1 coin (or clip) placed on compressor, on the breast side

(compressor at 4,5 cm. from breast support plate).

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 C
AD
B

F. 4

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